job description
Join House of Franchise Inc as a Licensed Pharmacist and play a pivotal role in ensuring our pharmaceutical products meet all FDA regulatory requirements and compliance standards. Based in the vibrant hub of Canggu, Bali, you will oversee the adherence to local and international pharmaceutical laws, safeguarding both our company’s integrity and public health.
This is a unique opportunity to blend your pharmaceutical expertise with regulatory affairs in a dynamic, fast-paced environment. You will collaborate with cross-functional teams to maintain compliance, streamline processes, and contribute to the development of high-quality pharmaceutical solutions.
If you are a detail-oriented professional with a passion for healthcare compliance and a commitment to excellence, we invite you to apply and help us uphold the highest standards in the industry.
Responsibility
- Monitor and ensure compliance with FDA regulations and other applicable pharmaceutical laws.
- Review and approve product labeling, packaging, and promotional materials for regulatory adherence.
- Conduct internal audits to verify compliance with GMP (Good Manufacturing Practices) and other industry standards.
- Liaise with regulatory authorities to submit documentation, respond to inquiries, and resolve compliance issues.
- Develop and implement SOPs (Standard Operating Procedures) for regulatory processes.
- Stay updated on changes in pharmaceutical laws and advise management on necessary adjustments.
- Collaborate with R&D, production, and quality assurance teams to ensure product compliance from development to distribution.
- Maintain accurate records of regulatory submissions, approvals, and correspondence.
Qualifications
- Bachelor’s degree in Pharmacy (or equivalent) with a valid pharmacist license.
- Minimum of 2-3 years of experience in regulatory affairs, compliance, or a related field.
- In-depth knowledge of FDA regulations, GMP, and pharmaceutical compliance standards.
- Strong analytical and problem-solving skills with attention to detail.
- Excellent written and verbal communication skills in English.
- Ability to work independently and manage multiple priorities in a fast-paced environment.
- Proficiency in Microsoft Office and regulatory management software.
- Familiarity with ASEAN pharmaceutical regulations is a plus.